Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran Vaccines in the United States

The main objective of the study is to evaluate the safety of the elasomeran/davesomeran and andusomeran vaccines as used in routine clinical practice.

Inclusion Criteria:

Cohort 1: Influenza vaccinated concurrent comparator

Eligible vaccine episodes must meet the following inclusion criteria within the protocol-specified time windows:

• Non-missing sex: (start of available data, 1 day prior to index)
• No receipt of elasomeran/davesomeran and andusomeran vaccine: (90 days prior to index, 1 day prior to index)
• No receipt of influenza vaccine: (90 days prior to index, 1 day prior to index)
• No receipt of any other COVID-19 vaccine: (90 days prior to index, index date)
• Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date)

Cohort 2: Medically attended COVID-19 concurrent comparator

Eligible vaccine and disease episodes must meet the following inclusion criteria within the specified time windows:

• Non-missing sex: (start of available data, 1 day prior to index)
• No receipt of elasomeran/davesomeran and andusomeran vaccine: (180 days prior to index, 1 day prior to index)
• No evidence of medically attended COVID-19: (180 days prior to index, 1 day prior to index)
• No receipt of any other COVID-19 vaccine: (180 days prior to index, index date)
• Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date)

Exclusion Criteria:

• Vaccine and disease episodes with a prior AESI within the washout window will be excluded from the analytic cohort.
• For the influenza vaccinated concurrent comparator cohort, individuals who receive an elasomeran/davesomeran and andusomeran vaccine and an influenza vaccine on the same day or within a minimum number of days will be excluded from the primary analysis.

Note: Other protocol-defined inclusion/exclusion criteria may apply.